A Prospective, Multi-Center Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor

- candidate number

16693

- NTR Number

NTR4476

- ISRCTN

ISRCTN no longer applicable

- Date ISRCTN created

- date ISRCTN requested

- Date Registered NTR

6-mrt-2014

- Secondary IDs

CTP-0004 Senseonics Trial

- Public Title

A Prospective, Multi-Center Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor

- Scientific Title

A Prospective, Multi-Center Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor

- ACRONYM

PRECISE

- hypothesis

The purpose of this clinical investigation is to evaluate the accuracy of the Senseonics Continuous Glucose Monitoring System (Senseonics CGM System) measurements when compared with reference standard measurements (YSI glucose analyzer). The investigation will also evaluate safety of the Senseonics CGM System usage, while in the clinic and during home use.

1. Males and Females ≥18 years of age.
2. Clinically confirmed diagnosis of diabetes mellitus for a duration of 1 year and uses insulin therapy for their diabetes management (including subjects on insulin pump therapy).

- Exclusion criteria

1. History of severe hypoglycemia in the last 6 months prior to study start
2. Diabetic ketoacidosis in the past 6 months.
3. Any condition preventing or complicating the placement, operation or removal of the Sensor including upper extremity deformities or skin condition.
4. Any medical condition or illness that in the judgment of the investigator might interfere with the procedures, results or compliance during the course of this investigation, or increase the risk of induced hypoglycemia or repeated blood testing including significantly impaired hepatic function and renal failure.

- mec approval received

no

- multicenter trial

yes

- randomised

no

- group

Parallel

- Type

Single arm

- Studytype

observational

- planned startdate

30-mei-2014

- planned closingdate

15-mrt-2015

- Target number of participants

82

- Interventions

N/A

- Primary outcome

The primary effectiveness endpoint will be evaluated in a test of superiority to a pre-specified performance goal for accuracy. Mean absolute relative difference (MARD) of Sensor readings will be compared with the reference measurements (YSI) at successive 30-days intervals through 180 days post-insertion. for reference glucose values greater than 75 mg/dL (4.2 mmol/L

- Secondary outcome

1. Mean absolute difference for reference glucose values less than 75 mg/dL (4.2 mmol/L).
1.2. Additional accuracy measures during the period of Sensor use – mean absolute difference; median absolute relative difference; agreement as expressed by readings within 20%, 30% and 40% of reference values; trend accuracy measured over time at different glucose rates of change and starting ranges

The Senseonics CGM System consists of : (1) a small Sensor, (approximately 3.3 mm [0.130”] diameter x 15.7 mm [0.620”] length) which has a ring that elutes the steroid dexamethasone; (2) a battery-powered external Transmitter (“Transmitter”); and (3) a Mobile Medical Application (MMA) for display of glucose information that runs on a Handheld Device (HHD). Accessories to the system include a blunt dissector for creating a pocket under the skin and an insertion tool used to place the Sensor into the pocket. The Transmitter, worn externally over the Sensor insertion site, powers the Sensor and receives signals from the Sensor across the skin. The Sensor does not contain a battery or other stored power source; instead it is powered discretely, as needed, by a simple inductive magnetic link between the two components. Between readings, the Sensor remains electrically dormant and fully powered down. At each query (set to a default of approximately every two minutes with a duration of 60 milliseconds) the Transmitter first sends the power (via magnetic link) to activate the Sensor, then uses this same magnetic link to capture the reading. This operational mode is commonly referred to as “speak when spoken to.” Finally, the Transmitter calculates the measured glucose value, the rate of change in glucose and all alarms that need to be alerted to the user. This information is then transmitted via Bluetooth Low Energy with AES-CCM encryption to the Mobile Medical Application and the subject is alerted to the alarms through activation of the vibratory motor within the Transmitter. The Mobile Medical Application displays glucose values, trends, and graphs as well as alerts. The Transmitter also contains digital storage media that enable extended data and profile information to be retrieved, downloaded to a computer or other electronic device, and reviewed by the physician or subject.